MEDICINES AUTHORITY

Introduction

The Inspectorate and Enforcement Directorate is a key Directorate within the Medicines Authority which, as detailed in the Medicines Act 2003, is responsible for:

1.     The inspection and licensing of the manufacture, distribution and sale of medicinal products. Active Pharmaceutical Ingredients (API`s) will also fall within the portfolio of the Directorate as from October 2005.

2.      The inspection and licensing of public and retail pharmacies.

3.     The certification for export and issue of certificates of Pharmaceutical Products and GMP certificates for locally manufactured medicinal products

4.      The provision of advice to the Licensing Authority in relation to the activities falling within its remit

5.      The enforcement of standards and the provisions of the Medicines Act 2003.

Staff complement

The Directorate staff complement comprises a Director, five Inspectors and an administrator.

Activities

The activities of the Directorate mainly include:

1.     The inspection of the various pharmaceutical activities including a) manufacture of finished dosage forms, API`s, and investigational medicinal products for use in clinical trials b) importation c) wholesale dealing d) partial manufacture/assembly  and e) pharmacies, and to verify compliance with GxP standards as stipulated in the Medicines Act 2003 and EU Directives.

2.      The licensing of the above mentioned pharmaceutical activities.

3.      Monitoring of GxP standards during the licence period.

4.      The provision of export certificates to local manufacturers for medicinal products.

5.      The market surveillance and enforcement of regulations and standards as part of the  inspection and follow-up process.

6.     The management of a product defect reporting system and coordinating all product recalls

7.     Investigation of possible breaches of legislation relating to unauthorised manufacture, importation, wholesale dealing, advertising, marketing of medicinal products, and or breaches of marketing authorisations or other licenses. These duties are discharged as part of the enforcement activities.

EU Legislation

Maltese Legislation

Inspections

Inspections are carried out by Medicines Inspectors of the Authority in order to assess compliance with the provisions of the Medicines Act 2003 as well as EU standards relating to the specific activity. Inspections are always performed when a new application is received. Upon the outcome of the inspection findings a licence can be recommended or rejected. Routine follow-up inspections are also carried out. Surprise inspections may be warranted in specific circumstances or following a complaint.

Inspections constitute a major activity within the Directorate and are considered as being crucial in ascertaining that the conditions of the licence are met.

GMP and GDP Inspections

These inspections are aimed at establishing the compliance, or otherwise, with GMP and GDP requirements and standards as laid down in the Medicines Act 2003 and EU legislation..

http://www.emea.eu.int

Pharmacy Standards - Pharmacy inspections are aimed at verifying that the conditions and standards as laid down in the Medicines Act 2003 are met.

Standards of Quality for Pharmacy Services

Pharmacies in Malta/Roster

List of Pharmacies in Malta

Legal classification status of medicines - The legal classification status of medicines will be assigned as part of the Marketing Authorisation for each specific product.

List of Marketing Authorisations issued

For products that are not yet covered by a Marketing Authorisation, Pharmacists should be guided by L.N.200 of 2004

Licensing

Licenses for the various pharmaceutical activities are issued upon establishing that the relevant GxP requirements and provisions of the Medicines Act are achieved. If during the licence period it results that the standards of good practice are not met or that any other provision of the Medicines Act is not abided to the licence can be revoked, suspended or varied.

  Application for a wholesale dealer's licence for medicinal products for human use
Revised  - 17/02/2005   

  Application for Qualified Person (QP) Status    - 18/01/2006

  Application for an import licence for medicinal products for human use - 18/01/2006

  Application for a Manufacturers Licence for Medicinal products for Human Use  -  18/01/2006   

 Application for variation to a manufacturer's, importer's or wholesale dealer's licence  Revised - 21/12/2004

Application for a Certificate of GMP Compliance of a Manufacturer  Revised - 21/12/2004

Application for a Manufacturer's and/or Importer's Licence for Investigational Medicinal Products  Revised - 30/03/2005

Notes for completing an application form for a Manufacturer's and/or Importer's Authorisation for Investigational Medicinal Products (IMPs)   Revised 21/12/2004

Guidance note regarding Medicinal Product Defect Reporting   - 18/01/2006

Medicinal Product Defect Reporting Form - 18/01/2006  

Certification

 Application for a Certificate of a Pharmaceutical Product Revised 15/09/2004

Recalls

  Pulmicort 200 microgram/dose pMDI (Class II Medicines Recall)   03/11/2004

  Diclogesic 12.5mg Suppositories (Class II Medicines Recall)    12/08/2004

  Amsidine 75mg ampoules, solution for infusion (Class 2 Medicines Recall)    03/06/2004

Qualified Persons

  Qualified Person (QP) Eligibility Interviews 4th-7th May 2004 

Inspectorate events

  Seminar - The Role of the Qualified Person in the Regulation of Medicines for Human use.